FDA.reportPublic FDA data

Workflow Box

Primary DI
B334WORKFLOWBOX2P40
Brand
Workflow Box
Company
MIRADA MEDICAL LIMITED
Model
2.4
Published
2020-11-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LLZSystem, Image Processing, Radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LLZSystem, Image Processing, RadiologicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K181572000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K181572000Workflow BoxMirada Medical, Ltd.2018-07-10QKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B334WORKFLOWBOX2P40PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Radiology picture archiving and communication system workstationA freestanding, image processing device that is a component of a picture archiving and communication system (PACS) for radiology designed to be networked with a wide variety of diagnostic imaging systems [e.g., x-ray, nuclear medicine, magnetic resonance imaging (MRI) or ultrasound (US), as well as a laboratory or hospital information system (HIS)]. It does not contain controls for the direct operation of a diagnostic imaging system and is designed to receive, archive, and transmit data both on-line and off-line. It is configured to provide limited or extensive capabilities to further process, manipulate and/or view patient images and information collected from diagnostic imaging systems.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
877.872.2617support@mirada-medical.com

Regulatory Flags#

DUNS number
211100325
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B334SY2P160Simplicit90Y2.162025-02-10
B334RTX1P100RTx1.102024-10-29
B334SY2P120Simplicit90Y2.122024-02-26
B334XD4P20XD4.22024-02-07
B334SY2P10Simplicit90Y2.102023-08-23
B334XD4P00XD4.02022-05-05
B334SY2P60Simplicit90Y2.62021-08-26
B334WORKFLOWBOX2P60Workflow Box2.62021-05-04
B334SY2P40Simplicit90Y2.42020-12-22
B334ALINE1P00Aline Ablation Intelligence1.02020-11-30
B334DBX1P40DBx1.42020-10-08
B334WORKFLOWBOX2P20Workflow Box2.22020-04-09
B334SY2P20Simplicit90Y2.22019-10-11
B334NMX4P20XD Nuclear Medicine4.22016-11-23
B334NMX4P40XD Nuclear Medicine4.42018-05-23
B334RTX1P60RTx1.62017-03-28
B334RTX1P80RTx1.82018-03-16
B334SY2P00Simplicit90Y2.02019-02-15
B334WORKFLOWBOX2P00Workflow Box2.02018-11-20
B334XD3P60XD3.62016-10-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M722CP26183V261830ClearRead CT Platform DockerRiverain Technologies, Inc.LLZ2026-07-17
00854393006084VelocityVARIAN MEDICAL SYSTEMS, INC.LLZ2026-07-16
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06938396401528SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.LLZ2026-07-10
06938396401559SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.LLZ2026-07-10
06938396401566SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.LLZ2026-07-10
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06938396401719SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.LLZ2026-07-10
06938396410124SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.LLZ2026-07-10
04260483290305MeVis AVM ContourMeVis Medical Solutions AGLLZ2026-07-09
G775EVOLVE4140EVOLVESmaart Medical Systems, Inc.LLZ2026-07-09
080563044562053mensio WorkstationPie Medical Imaging B.V.LLZ2026-07-08
00850059977576TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-07-03
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00850059977545TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-06-26
00850059977552TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-06-26
00850059977569TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-06-26
00889024673403NavitrackER®Orthosoft IncLLZ2026-06-26
00889024699762ROSA® ShoulderOrthosoft IncLLZ2026-06-26
00889024699779ROSA® ShoulderOrthosoft IncLLZ2026-06-26
00889024699786ROSA® ShoulderOrthosoft IncLLZ2026-06-26